Opdivo (nivolumab) Demonstrates Long Term Survival Benefit in Patients with Previously Treated Non-Squamous Non-Small Cell Lung Cancer in CheckMate -057

Bristol-Myers Squibb Company BMY today announced longer term (18 month) survival data from CheckMate -057, an open-label, randomized Phase 3 study evaluating Opdivo (n=292) versus docetaxel (n=290) in previously treated patients with advanced, non-squamous (NSQ) non-small cell lung cancer (NSCLC). Opdivo continued to demonstrate superior overall survival (OS) – the study's primary endpoint – with an estimated 39% of patients alive at 18 months (95% CI, 34-45) versus 23% for docetaxel, based on a minimum follow-up of 17.1 months. Opdivo also continued to demonstrate a reduction in the risk of death by 28% (a hazard ratio of 0.72; 95% CI, 0.60 - 0.88). In the study, Grade 3-4 treatment-related adverse events were reported in 10% of patients treated with Opdivo versus 54% in the docetaxel arm. These data will be presented on Monday, September 28 during the 2015 European Cancer Congress (ECC 2015) (Abstract # 3010) and published in the New England Journal of Medicine. "These longer term survival results for nivolumab in advanced, non-squamous non-small cell lung cancer support the potential for this Immuno-Oncology agent in treating lung cancer patients," said Leora Horn, M.D., Vanderbilt-Ingram Cancer Center. "CheckMate -057 builds upon its critical findings and now, data show a sustained survival benefit for nivolumab in this hard-to-treat disease that is incredibly encouraging for oncologists, and most importantly, for our patients." CheckMate -057 clinical results were first reported at the 51st Annual Meeting of the American Society of Clinical Oncology, marking the first time a PD-1 inhibitor demonstrated superior OS versus docetaxel in previously treated patients with NSQ NSCLC. Data from this trial have been accepted for regulatory review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency to expand the respective Opdivo indications to include previously treated patients with NSQ NSCLC. This application has also been granted Priority Review in the U.S., and Opdivo has received Breakthrough Therapy Designation for this indication. "At the core of our Immuno-Oncology approach is an unrelenting focus to fundamentally change survival expectations for all cancer patients. Today, we are driving insights into how advanced lung cancer may be treated – from defining the role of PD-L1 expression to showing clinical efficacy resulting in deep and durable responses for these patients," said Michael Giordano, senior vice president, head of Development, Oncology. "The 18-month data from CheckMate -057 reinforce the potential for Opdivo, across PD-L1 expression levels, to offer patients durable overall survival benefit with lower incidence of serious adverse events versus chemotherapy."